🧫 Job Title: Manager, Drug Substance Continuous Improvement – Vaccines (Equipment Qualification)
📍 Location: Swiftwater, Pennsylvania
💰 Salary Range: USD 67,500.00 – 97,500.00
🏢 Company: Sanofi
#LI-Onsite | #GD-SP | #LI-SP | #vhd
🌍 About Sanofi
Sanofi is a global healthcare company that helps the world stay ahead of infectious diseases by delivering over 500 million vaccine doses annually.
With cutting-edge automation, AI-driven manufacturing, and smart facilities, we ensure that treatments reach patients faster, safer, and more sustainably.
At Sanofi, your skills, ambition, and passion can directly shape the future of healthcare as we pursue progress and chase the miracles of science every single day.
⚙️ About the Job
As a Manager, Drug Substance Continuous Improvement (Equipment Qualification), you’ll lead and execute projects to enhance operational performance in vaccine manufacturing.
Your focus will be on equipment qualification, process optimization, and continuous improvement initiatives, ensuring all operations meet cGMP and industry standards.
You’ll act as a technical liaison between manufacturing, quality, and external vendors, driving excellence in equipment performance and process reliability.
🔧 Main Responsibilities
Lead and execute projects involving equipment qualification from conception to completion.
Develop and implement change controls, protocols, test scripts, and documentation for small to medium-sized projects.
Collaborate with equipment vendors for procurement, qualification, and performance optimization.
Serve as a Subject Matter Expert (SME) on equipment qualification methodologies within drug substance manufacturing.
Ensure all qualification and validation activities comply with cGMP standards and regulatory requirements.
Partner with Operations, Quality, Automation, Maintenance, and Manufacturing Technology teams to troubleshoot and resolve equipment issues.
Lead and implement process improvement and root cause analysis (RCA) initiatives.
Gather and report on performance issues and improvement opportunities identified on the shop floor.
Actively promote and implement safe work practices and ensure a strong safety culture across all teams.
Support deviation investigations and provide documentation updates as needed.
🧩 Job Context & Challenges
Identify and resolve manufacturing equipment issues impacting productivity or compliance.
Drive operational excellence and continuous improvement across manufacturing functions.
Serve as SME for manufacturing process equipment and support related improvement projects.
Manage multiple priorities and small-to-medium scale projects simultaneously.
Collaborate across functions to ensure alignment between production, quality, and engineering.
🧠 About You
Basic Qualifications
Bachelor’s degree in Mechanical, Industrial, or Manufacturing Engineering (or a related technical field).
Minimum 3 years of experience in a regulated manufacturing environment (GMP/GxP preferred).
Strong understanding of cGMP standards, Continuous Improvement (CI) principles, and equipment qualification.
Proven ability to lead cross-functional teams with excellent communication and leadership skills.
Preferred Qualifications
Certification in Lean Manufacturing, Six Sigma, or other CI methodologies.
Experience in equipment qualification, process validation, and technical documentation.
Familiarity with deviation management, CAPA, and root cause analysis (RCA) tools.
Additional certifications or technical training in manufacturing or quality systems are a plus.
🌟 Why Choose Sanofi?
Be part of a future-focused global leader in vaccine innovation.
Access endless career growth opportunities through global mobility, promotions, and lateral moves.
Benefit from a competitive compensation and rewards package recognizing your performance.
Enjoy comprehensive health and wellbeing programs, including:
High-quality healthcare and prevention programs
Wellness and mental health support
14 weeks of gender-neutral parental leave
⚖️ Equal Opportunity Statement
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action Employers, committed to a diverse and inclusive workforce.
All qualified applicants will receive consideration without regard to race, color, religion, national origin, sex, gender identity or expression, age, sexual orientation, disability, veteran status, or any other characteristic protected by law.
🚀 Join Us — Pursue Progress. Discover Extraordinary.
At Sanofi, we invest in your growth so you can reach further, think faster, and achieve what’s never been done before.
Together, we’ll push boundaries, challenge convention, and deliver smart solutions that transform lives around the world.
📺 Watch “One Day at Sanofi” and explore our DEI initiatives at sanofi.com
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